GUDAIR
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
21-08-2013
Summary of Product characteristics
(SPC)
21-08-2013
Active ingredient:
mycobacterium paratuberculosis inactivated 2.5 mg
Available from:
CZ VETERINARIA
ATC code:
QI03AB01
Pharmaceutical form:
Emulsion for injection
Therapeutic group:
Mycobacterium
Therapeutic area:
Goats Food, Sheep Food
Authorization date:
2013-06-27
Patient Information leaflet
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GUDAIR
Emulsion for injection for sheep and goats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1ml) of the vaccine contains:
ACTIVE SUBSTANCE:
_Mycobacterium paratuberculosis_ inactivated, strain 316F
≥ 2 mm ITT avian PPD*
*Increase of the skin thickness in the intradermal tuberculin test in sheep with avian
protein derivative and in comparison with bovine protein derivative.
ADJUVANT(S):
Mineral oil (Marcol 52)
0.38 mL
Montanide 103
0.021 mL
Montane 80
0.021 mL
EXCIPIENTS:
Thiomersal
0.1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and goats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_ _
Active immunisation of sheep and goats to reduce clinical signs, lesions and mortality
caused by M. paratuberculosis. It also reduces _M. paratuberculosis_ faecal shedding in
sheep.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccination sensitises animals against johnin PPD (Purified Protein Derivative of
_Mycobacterium avium_ subsp. _paratuberculosis_), avian tuberculin PPD (derivative of
_Mycobacterium avium_) and to lesser extend bovine tuberculin PPD (derivative of
_Mycobacterium bovis_). The reaction against avian tuberculin PPD is more intense than
against bovine tuberculin PPD and clearly distinguishable.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use uninterruptedly once the extracti
Read the complete document
Summary of Product characteristics
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GUDAIR
Emulsion for injection for sheep and goats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1ml) of the vaccine contains:
ACTIVE SUBSTANCE:
_Mycobacterium paratuberculosis_ inactivated, strain 316F
≥ 2 mm ITT avian PPD*
*Increase of the skin thickness in the intradermal tuberculin test in sheep with avian
protein derivative and in comparison with bovine protein derivative.
ADJUVANT(S):
Mineral oil (Marcol 52)
0.38 mL
Montanide 103
0.021 mL
Montane 80
0.021 mL
EXCIPIENTS:
Thiomersal
0.1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and goats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_ _
Active immunisation of sheep and goats to reduce clinical signs, lesions and mortality
caused by M. paratuberculosis. It also reduces _M. paratuberculosis_ faecal shedding in
sheep.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccination sensitises animals against johnin PPD (Purified Protein Derivative of
_Mycobacterium avium_ subsp. _paratuberculosis_), avian tuberculin PPD (derivative of
_Mycobacterium avium_) and to lesser extend bovine tuberculin PPD (derivative of
_Mycobacterium bovis_). The reaction against avian tuberculin PPD is more intense than
against bovine tuberculin PPD and clearly distinguishable.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use uninterruptedly once the extracti
Read the complete document
